510(k) K801660
K801660 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "PROXIMATE * PSD PURSE-STRING DEVICE". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- July 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type